There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This is a first-in-human, open-label, multi-center, Phase 1 study of RO6927005. The study will establish the safety and tolerability profile of RO6927005 and will be conducted in two parts. In Part A, the first dose escalations will be carried out using cohorts of 1 patient. Single patient cohorts will be used to investigate increasing doses until a first dose-limiting toxicity (DLT) is reached or until grade-2 related toxicity (except infusion-related reactions), whichever comes first. At least 3 patients will be enrolled in each cohort thereafter, which, if required, can be expanded with additional patients. Part B of the study will consist of a multiple ascending dose phase (multiple patients cohorts - >/= 3 patients) followed by an extension phase of RO6927005 given in combination with gemcitabine/nab-paclitaxel. Preliminary clinical activity will be explored throughout the study. Patients will be treated until disease progression and/or lack of clinical benefit, unacceptable toxicities, withdrawal from treatment for other reasons, death, pregnancy or termination of the study by the Sponsor, whichever comes first.
Background: - Fatigue is a common side effect of cancer and its treatment. No medications can treat this fatigue. Researchers want to see if the drug ketamine can improve fatigue after radiation therapy for cancer. They will compare the effects of ketamine on fatigue to midazolam, a sedative with similar effects. Objectives: - To better understand fatigue in people who completed radiation therapy for cancer. To look at the effects of a dose of ketamine on fatigue. Eligibility: - Adults 18 and older who completed radiation therapy for cancer and are enrolled in NIH protocol 08-NR-0132. Design: - Participants will be screened with medical history, physical exam, and blood and urine tests. They will complete questionnaires about their fatigue and take a breath alcohol test. - The study is divided into 2 phases: - During the first phase I visit, participants will have blood taken. They will talk about their fatigue and other symptoms. They will take thinking and handgrip strength tests. Then they will get either ketamine or placebo (midazolam) through an intravenous line, placed by a needle guided by a thin plastic tube into an arm vein. - Participants will have a follow-up phone call within 1 day. - Participants will have phase I visits 3, 7, and 14 days after infusion. For the 3- and 7-day visits, participants will take thinking and handgrip strength tests. They will complete questionnaires, talk about infusion side effects, and have blood taken. For the 14-day visit, they will talk about their fatigue and infusion side effects. They will start phase II that day. - Phase II visits are the same as phase I, except that the 14-day visit is over the phone.
In this study, 50 evaluable patients will undergo one FDG-PET study during their chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax, FDGhetero, and texture maps will be obtained. Evaluating the changes in tumor SUVmax and heterogeneity during treatment will aid in better understanding the role of these biological parameters in inadequate response to chemoradiation. Other researchers, using MRI imaging, have evaluated changes in the cervical tumor volume during treatment. The investigators expect there will be variation in how cervical tumors shrink and change during chemoradiation and therefore we are going to use multiple measures in addition to tumor volume to evaluate cervical tumor metabolic heterogeneity. Being able to predict at diagnosis the patients who are at higher risk for persistent disease following chemoradiation would allow for future studies where these high risk patients could be specifically targeted with more aggressive therapy.
The purpose of this study is to assess the differential expression of AD biomarkers in serum, plasma, and skin biopsies from both lesional and non-lesional skin in moderate to severe AD patients in the presence of TCS and after withdrawal from TCS.
The overall goal of this clinical study is to characterize the fusion rate of geneX® ds bone graft substitute in comparison to autograft, which is considered the gold standard for posterolateral fusion. Assessments are made using AP and Lateral x-rays, F/E x-rays, and CT scans geneX® ds has been cleared by the FDA for use in these procedures; however this study will allow more detailed characterization of geneX® ds performance in the long-term (1 year). By using the patient as their own control, direct comparison to autograft can be performed while minimizing other variables.
This pilot study will seek to use emotion recognition technology from video to link patient facial expressions, heart rate and respiratory rate changes, and movement patterns to patient pain scores.
This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste).
Thyroid eye disease (TED) is an autoimmune inflammation of the orbital tissues that develops in up to 50% of patients with Graves' disease. Although about 80% respond to IVGC initially, the relapse rate is high and about 75% require further surgery despite initial response. Although the natural history of TED is associated with spontaneous remissions after about 1 to 3 years, many irreversible serious ophthalmic and orbital complications can arise during this time. Therefore, there is a need for improved intervention strategies in the early active inflammatory phase of TED, to avoid progression to the cicatricial stage where disease manifestations can only be addressed in a rehabilitative fashion. The primary immunopathogenesis of Graves' disease is considered to be activation of B cells that then produce autoantibody against thyrotropin receptors in the thyroid (TRAb). Like in many autoimmune diseases, the inflammatory CD4+ T cell subset known as Th17 cells is also increased in blood of patients with active Graves' disease; the putative Th17 cytokine, IL-17, is also increased in serum and tears of TED patients. There is also an emerging pathogenic role for Th17 cells that co-express the chemokine receptor CXCR5 and drive autoantibody production. The contribution of Th17 cells to TED is not well defined. This study is an observational, longitudinal, prospective study of patients receiving treatment for thyroid eye disease.
This study will determine whether the supplemental use of chemical pocket disinfection with scaling and root planing is more effective than scaling and root planing alone in clinically reducing periodontal probing depth (PD), reducing bleeding on probing (BOP), and gaining clinical attachment level (CAL). It also will assess whether chemical pocket disinfection with scaling and root planing will have an effect on biomarkers of inflammation.
This randomized phase II trial studies the side effects and how well postoperative intensity modulated radiotherapy works after surgery in treating patients with urothelial bladder cancer. Radiation therapy uses high energy x-rays to kill tumor cells left behind in the pelvis after surgery. It is not yet known whether surgery followed by radiotherapy is more effective than surgery alone in treating patients with urothelial bladder cancer.